RATIONALE: Collecting and storing samples of blood and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

Identify unique proteins or peptides that are associated with prostate cancer by comparing the proteomic or metabolomic analysis of serum, plasma, and urine from patients with histological evidence of prostate cancer to those without prostate cancer (after transrectal ultrasound prostatic biopsy).

Secondary

Collect seminal fluid from a subset of patients to test the hypothesis that the fluid collected from the "target organ of injury" in prostate cancer will have a higher signal of proteins/peptides that are different from those without cancer and may help guide the identification of these differences in the serum, plasma, and urine.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Study Type ICMJE

Observational

Study Design ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ICMJE

Prostate Cancer

Intervention ICMJE

Genetic: proteomic profiling

Other: immunological diagnostic method

Other: laboratory biomarker analysis

Other: mass spectrometry

Procedure: biopsy

Procedure: ultrasound imaging

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Estimated Enrollment ICMJE

60

Completion Date

Not Provided

Primary Completion Date

July 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

DISEASE CHARACTERISTICS:

Indication for a transrectal ultrasonography prostatic biopsy (as part of normal patient care) due to elevated prostate-specific antigen, or abnormal digital rectal examination, or surveillance for prostate cancer

PATIENT CHARACTERISTICS:

No prior or other concurrent malignancy except for curatively treated basal cell carcinoma of the skin

No serious medical or psychiatric illness that would preclude informed consent

No concurrent acute illness

PRIOR CONCURRENT THERAPY:

No participation in another clinical trial within the past 30 days

No more than one enrollment into this study

Sex/Gender

Sexes Eligible for Study:

Male

Ages

18 Years to 120 Years (Adult, Senior)

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects